CK Group are recruiting for a Regulatory Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis initially for 12 months.
£75.79 per hour Umbrella
Regulatory Executive Role:
- Manage the development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information
- Support regional and country product information (prescriber and patient), primarily in the EU and APJEM markets
- Authoring, development and maintenance of EU product information and Global Product Information (PI), in conjunction with functional experts.
- Authoring of the patient information in the Global Patient Leaflet (GPL).
- Generation of responses to regulatory agency questions related to prescriber and patient information.
- Life sciences degree (Pharmacy preferred) or relevant experience, or PhD or equivalent relevant experience.
- Relevant experience includes pharmacy practice, regulatory affairs, medical affairs, clinical research, or pharmacovigilance.
- Excellent Scientific Regulatory Writing ? the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
- Data analysis skills ? basic understanding of biostatistics, clinical trial design, and clinical therapeutics
- Therapeutic / Product Knowledge. Will have knowledge of therapeutic area(s), particularly the HIV area, and be developing a sound knowledge of a product portfolio.
- Regulatory Knowledge and basic understanding of policy and processes relating to management of prescriber, patient and pack information.
Our client is a global healthcare company, taking on some of the world\'s biggest healthcare challenges.
This Regulatory Executive role is home based with Covid restrictions are in effect but will then probably be based at our clients site in Brentford, Greater London.
Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Heather Deagle
- Phone: 0191 384 8905
- Reference: 51015
Website: CK Group
- Posted: 9th September 2021
- Expires: 7th October 2021